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Study of Denosumab vs. Zoledronic Acid to Treat Bone Metastases in Men With Hormone-refractory Prostate Cancer
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00321620
First received: May 2, 2006
Last updated: February 19, 2016
Last verified: February 2016
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Purpose
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases in men with hormone-refractory prostate cancer
| Condition | Intervention | Phase |
|---|---|---|
| Bone Metastases | Drug: zoledronic acid Biological: denosumab | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa®) in the Treatment of Bone Metastases in Men With Hormone-Refractory Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by Amgen:
Primary Outcome Measures:
- Time to the First On-Study SRE (Non-inferiority) [ Time Frame: Up to 40.5 months ]Time to the first on-study skeletal-related event (SRE) analyzed for non-inferiority. Kaplan-Meier estimates of the median and its dispersion are reported.
Secondary Outcome Measures:
- Time to the First On-Study SRE (Superiority) [ Time Frame: Up to 40.5 months ]Time to the first on-study skeletal-related event (SRE), analyzed for superiority of denosumab. Kaplan-Meier estimates of the median and its dispersion are reported.
- Time to the First-And-Subsequent On-Study SRE [ Time Frame: Up to 40.5 months ]
Time to the first-and-subsequent on-study skeletal-related event (SRE), analyzed for superiority of denosumab using multiple event analysis, the event must occur at least 21 days after the previous SRE.
This outcome measure utilizes multiple event times, was analyzed based on a proportional mean model, and is therefore more appropriately summarized by the cumulative mean number of events.
| Enrollment: | 1904 |
| Study Start Date: | April 2006 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: zoledronic acid |
Drug: zoledronic acid
Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC
Other Name: Zometa
|
| Experimental: denosumab |
Biological: denosumab
Q4W 120 mg denosumab SC and 4 mg zoledronic acid placebo IV over a minimum of 15 minutes
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men >/= 18 years of age with histologically confirmed prostate cancer
- Radiographic evidence of at least one bone metastasis
- Failure of at least one hormonal therapy as evidenced by a rising PSA
- Serum testosterone level of <50 ng/dL
- ECOG PS 0, 1, or 2
- Adequate organ function
Exclusion Criteria:
- Current or prior IV bisphosphonate administration
- Current or prior oral bisphosphonates for bone mets
- Life expectancy of less than 6 months
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321620
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321620
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT00321620 History of Changes |
| Other Study ID Numbers: |
20050103 |
| Study First Received: | May 2, 2006 |
| Results First Received: | December 10, 2010 |
| Last Updated: | February 19, 2016 |
Keywords provided by Amgen:
|
Bone metastases Hormone-refractory prostate cancer Skeletal |
Fractures Compressions Bisphosphonates |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Bone Neoplasms Bone Marrow Diseases Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Neoplastic Processes |
Pathologic Processes Bone Diseases Musculoskeletal Diseases Hematologic Diseases Hormones Zoledronic acid Diphosphonates Denosumab Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on July 17, 2017